Children’s ibuprofen recall overview:
- Who: Strides Pharma is recalling nearly 90,000 bottles of Children’s Ibuprofen Oral Suspension.
- Why: The recall is due to reports of a foreign substance, including a gel-like mass and black particles, found in the product.
- Where: The recall is effective nationwide in the United States.
Strides Pharma has issued a recall for nearly 90,000 bottles of Children’s Ibuprofen Oral Suspension after reports surfaced of contamination with foreign substances.
The Children’s Ibuprofen Oral Suspension, with a concentration of 100 mg per 5mL, is packaged in 4 fl oz (120 mL) bottles and bears the National Drug Code 51672-5321-8. The affected lots are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.
The recall was initiated on March 2 following complaints about the presence of a gel-like mass and black particles in the liquid ibuprofen, which is intended for children aged 2 to 11.
The product, manufactured in India by Strides Pharma for Taro Pharmaceuticals, comes in a berry flavor and is used to alleviate pain and reduce fever.
The recall affects products distributed across the United States and is aimed at preventing potential health risks to children.
Contaminated children’s ibuprofen poses temporary health risks, recall warns
The U.S. Food and Drug Administration (FDA) classified this as a Class II recall, indicating that exposure to the product could lead to temporary or medically reversible adverse health consequences. “The medication was distributed nationwide,” the FDA stated in its notice.
The Ibuprofen recall notice emphasizes the need for consumers to check their medicine cabinets and discontinue use of the affected products immediately.
Strides Pharma is working to address the issue by removing the affected lots from the market. The company has communicated with distributors and retailers to ensure the recall is effectively implemented and contaminated products are withdrawn from circulation.
For more information about the recall, consumers can contact Strides Pharma at its Bridgewater, New Jersey office at (609) 773-5000. Further details can be found on the FDA’s website, where updates about the recall status will be posted.
Strides Pharma says it has not received any reports of illness related to the recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.
Are you affected by the Children’s Ibuprofen recall? Let us know in the comments.
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